21 NCAC 46 .2609             REHABILITATION EQUIPMENT

(a)  Rehabilitation equipment suppliers shall follow the provisions of this Rule rather than the provisions of 21 NCAC 46 .2611.

(b)  Rehabilitation equipment suppliers shall:

(1)           Solicit information from the physician, physical therapist, occupational therapist, registered nurse and other medical or educational personnel, as to the results of their assessment and evaluation of the patient's physical, functional and associated needs as well as the specific goals to be met by the enabling technology;

(2)           In consultation with the referring health professional(s), patient, patient's family and other primary care providers, delineate the appropriate choices of commercially available and custom fabricated equipment to meet the specified needs of the patient;

(3)           Participate in the measurement of the patient, utilizing appropriate instruments and techniques to assure the fit and function of the selected equipment;

(4)           Deliver, fit and adjust the prescribed equipment;

(5)           Instruct the patient and family in the safe and proper use and care of the equipment provided;

(6)           Provide service and support for the equipment delivered through knowledgeable, skilled and trained service personnel and within 72 hours, provide a response to patient requests for repair service on equipment supplied; however, such service and support need not be provided unless the patient=s account is current;

(7)           Provide a specific, written statement of warranty on the equipment provided, including commercial warranties and those for adapted or custom fabricated items;

(8)           Maintain liability insurance of at least one million dollars ($1,000,000) worth of coverage and when involved in the design, fabrication or substantial modification of commercially available equipment, also maintain product liability insurance; and

(9)           Utilize written, quality assurance procedures including, but not limited to:

(A)          Reviewing custom designed and fabricated equipment and interfacing techniques with commercial equipment to assure compatibility and safety;

(B)          Understanding the properties of the materials being used in custom designed and modified equipment to assure long term durability;

(C)          Documenting goals and objectives of the referring medical or education personnel, as well as short and long term effectiveness of the equipment in meeting those goals and objectives; and

(D)          Documenting complaints and problems as required in Rule .1608(a)(12) of this Chapter.

History Note:        Authority G.S. 90-85.3(e),(l1),(r); 90-85.6; 90-85.22;

Eff. September 1, 1995;

Amended Eff. April 1, 1999; April 1, 1997;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017.